INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)

Summary

This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM). The drugs involved in this study are : * Abemaciclib (arm is currently closed to accrual) * Temozolomide (temodar) * Neratinib (arm is currently closed to accrual) * CC115 (arm is currently closed to accrual) * QBS10072S

Timeline

Start

2017-02-09

Primary completion

2028-02-01

Completion

2028-04-30

Outcome

Missed primary endpoint

paper None of the experimental therapies demonstrated a significant OS benefit (P > .05). PMID 37722087 ↗

Publications

• Rudra Gupta T, Polley MC, Redd R, Lee EQ, Arrillaga-Romany I, Gilbert MR, Tan Y, Touat M, Drappatz J, Welch MR, Galanis E, Ahluwalia MS, Colman H, Nabors LB, Hepel J, Elinzano H, Schiff D, Chukwueke UN, Beroukhim R, Nayak L, McFaline-Figueroa JR, Batchelor TT, Kaley TJ, Lu-Emerson C, Mellinghoff IK, Bi WL, Arnaout O, Peruzzi PP, Haas-Kogan D, Tanguturi S, Aizer A, Doherty L, Santagata S, Meredith DM, Chiocca EA, Reardon DA, Ligon KL, Weller M, Mehta MP, Wen PY, Trippa L, Rahman R. Treatment Effect Reanalysis of the Randomized Individual Screening Trial of Innovative Glioblastoma Therapy in Newly Diagnosed Glioblastoma With External Control Data. J Clin Oncol. 2026 May 22:JCO2501586. doi: 10.1200/JCO-25-01586. Online ahead of print.
• Rahman R, Trippa L, Lee EQ, Arrillaga-Romany I, Fell G, Touat M, McCluskey C, Wiley J, Gaffey S, Drappatz J, Welch MR, Galanis E, Ahluwalia MS, Colman H, Nabors LB, Hepel J, Elinzano H, Schiff D, Chukwueke UN, Beroukhim R, Nayak L, McFaline-Figueroa JR, Batchelor TT, Rinne ML, Kaley TJ, Lu-Emerson C, Mellinghoff IK, Bi WL, Arnaout O, Peruzzi PP, Haas-Kogan D, Tanguturi S, Cagney D, Aizer A, Doherty L, Lavallee M, Fisher-Longden B, Dowling S, Geduldig J, Watkinson F, Pisano W, Malinowski S, Ramkissoon S, Santagata S, Meredith DM, Chiocca EA, Reardon DA, Alexander BM, Ligon KL, Wen PY. Inaugural Results of the Individualized Screening Trial of Innovative Glioblastoma Therapy: A Phase II Platform Trial for Newly Diagnosed Glioblastoma Using Bayesian Adaptive Randomization. J Clin Oncol. 2023 Dec 20;41(36):5524-5535. doi: 10.1200/JCO.23.00493. Epub 2023 Sep 18.
• Groot J, Ott M, Wei J, Kassab C, Fang D, Najem H, O'Brien B, Weathers SP, Matsouka CK, Majd NK, Harrison RA, Fuller GN, Huse JT, Long JP, Sawaya R, Rao G, MacDonald TJ, Priebe W, DeCuypere M, Heimberger AB. A first-in-human Phase I trial of the oral p-STAT3 inhibitor WP1066 in patients with recurrent malignant glioma. CNS Oncol. 2022 Jun 1;11(2):CNS87. doi: 10.2217/cns-2022-0005. Epub 2022 May 16.

Drugs

Indications